Corporate “Free Speech” Castrates the FDA

The First Amendment of the Constitution has surely sparked controversy over the decades. What is “free speech”? What are its limits?

It is generally agreed that yelling “Fire!” in a crowded theater is not protected under the First Amendment. And while the courts have ruled that political candidates can say virtually anything they like about rivals, truth be damned, this freedom doesn’t protect politicians from libel and slander lawsuits. Publicly threatening a public official with bodily harm is also against federal law (though such laws pretty much go unenforced anymore, at least for right-wing politicians, talking heads and celebrities).

This said, if you’re one of the new “Corporate Persons,” money is your protected “free speech” now, thanks to the Roberts Court and its Citizens United decision. However, corporations are still restrained from making unsubstantiated claims about products and services under the Federal Trade Commission’s Truth in Advertising regulations.

In today’s hyper-commercialized, cut-throat competitive world, it seems every major corporation is screaming to get your attention by assaulting you with ads at every turn in order to get you to buy, buy, buy. Given this state of affairs, it’s small wonder that Corporate America is constantly pushing the boundaries of those pesky “Truth in Advertising” regulations in the name of their First Amendment rights. And one of the worst corporate offenders in this regard is Big Pharma, which demonstrates time and again that it will gladly risk the health and lives of natural humans in order to maximize profits on their products – even if it does cost them a few million in judgments.

It started in 2008 with a case involving a salesman named Alfred Caronia, working for a company called Orphan Medical (now Jazz Pharmaceuticals). Meeting with prospective customers, Mr. Coronia was actively promoting the use of a medication for “off-label” purposes – in other words, using the drug to treat conditions for which it was not designed.

Qualified, licensed doctors are allowed to do this legally when, in their professional opinion, such off-label use would help the patient. A common example is the use of aspirin as an anti-coagulant. However, unless there has been thorough clinical testing and the Food and Drug Administration has given approval, a pharmaceutical company may not promote a product for such off-label use.

This is where Mr. Caronia ran afoul of the law. Taking his case to the 2nd Circuit Court of Appeals, Caronia’s lawyers argued that convicting their client for talking up off-label use of the drug in question was a violation of his First Amendent rights.

The government cannot prosecute pharmaceutical manufacturers and their representatives under the Food, Drug and Cosmetics Act for speech promoting the lawful, off-label use of an FDA-approved drug.

As long as an actual natural person from the company is actually speaking the words, there is no violation of the law.

Presently, the FDA has no plans to appeal the ruling. One reason may be that the ruling doesn’t affect current regulations in any meaningful way; Big Pharma still cannot actively promote off-label use in print or media ads. But when it comes to direct sales and spoken communication, its all fair game.

There are five other reasons why the FDA may be hesitating to appeal Judge Chin’s decision – and their names are Roberts, Scalia, Kennedy, Alito and Thomas. An appeal to a SCOTUS dominated by corporatist judges could be the death-knell of any regulation whatsoever.

And of course, simply being allowed to have salesmen without medical training promoting the drugs for off-label use isn’t enough for Big Pharma. This would seem to be surprising, given the injury lawsuits these companies have faced over unapproved off-label promotions (such as Glaxo-Smith Klineand Pfizer, which settled allegations of unlawful off-label marketing for billions of dollars). Nonetheless, a Big Phamra coalition, the “Medical Information Working Group” (which features such nefarious players as the aforementioned in addition to Johnson & Johnson, Novartis and Eli Lilly) is petitioning the FDA to ease up on its rules in light of the Caronia ruling and similar cases.

Not surprisingly, the FDA – increasingly in the back pocket of Big Pharma – has been under pressure to bow to the whims of the companies they’re supposed to be regulating. A bill currently making its way through a corporate-friendly Congress, given the flowery and progressive sounding name of “21st Century Cures,” would create a streamlined process for getting new drugs to the market more quickly. Not surprisingly, the corporate whores in Congress have added language that would further weaken FDA authority.

At stake are billions of dollars in profits. Given Big Pharma’s demonstrated willingness to put those profits over people (lawsuits amounting to the “cost of doing business” for such vampires), it bodes ill for patients. In the end, it may very well be physicians themselves that will have to stand between Big Pharma and patients. At least one health care facility in California has banned pharmaceutical company salespeople. Dr. Rita Redberg, who teaches at U.C. San Francisco told Reuters that such salespeople “are [not] a good source of information…you don’t ask the barber if you need a haircut.”

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.